Movement of Thoracic and Lumbar SkinNCT02105363
How Much Can the Thoracic and Lumbar Skin Slide?
An observational study of Movement of Thoracic and Lumbar Skin, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The investigators want to determine how much the skin on the back can move left to right of the midline and also up and down, in subjects presenting for procedure or in healthy volunteers. The investigators will do measurements on the back using samples of individuals in all age groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Movement of Thoracic and Lumbar Skin
- What is being tested?
- measure of skin movement on surface of the back and Measurement of skin movement on surface of back
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All individuals age 0-100
Who may be able to join
- Children age 0-17 and Adults 18 and older may participate
- You agree to participate and sign the informed consent document
Who cannot join
- Any type of back deformity
- Tumor on back
- Skin Disease on the back
- Any condition that prevents skin measurements such as scleroderma
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson Universtiy Hospital
New Brunswick, New Jersey, 08901
About this study
Official title: How Much Can the Thoracic and Lumbar Skin Slide? Unrecognized Cause of Epidural Catheter Placement Failure
The investigators want to determine how much the skin on the back can move left to right of the midline and also up and down, in subjects presenting for procedure or in healthy volunteers. The investigators will do measurements on the back using samples of individuals in all age groups.
It is hypothesized that an explanation to late epidural failure could be related to excess back motion in individual subjects.
- Conditions
- Movement of Thoracic and Lumbar Skin
- Being tested
- measure of skin movement on surface of the back, Measurement of skin movement on surface of back
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of skin movement on surface of the backOther
Measurement of skin movement on surface of backOther
| Study group | Role | What they receive |
|---|---|---|
| Age 11-15 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 16-20 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 21-25 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 26-30 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 31-35 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 36-40 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 41-45 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 46-50 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 51-55 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 56-60 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| age 61-65 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 66-70 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 71-75 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 76-80 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 81-85 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 86-90 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 91-95 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 96-100 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 0-5 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back | |
| Age 6-10 | Not described Receives: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar skin move greater than 4 cm laterally or cephala-caudal
Measured: Data entered day subject participates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: loss of research support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement of Thoracic and Lumbar SkinStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Pantin, Rutgers, The State University of New Jersey
- Investigators
- Enrique Pantin, MD, Principal investigator, Rutgers Robert Wood Johnson Medical SchoolAnn Marie Lozano, RN, MSN, Study chair, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105363
- Sponsor's protocol ID
- 2013003345
- Status last verified
- Jul 2019
- First submitted
- 25 Feb 2014
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Much Can the Thoracic and Lumbar Skin Slide? Unrecognized Cause of Epidural Catheter Placement Failure
- ClinicalTrials.gov ID
- NCT02105363
- Acronym / sponsor ID
- 2013003345
- Conditions
- Movement of Thoracic and Lumbar Skin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: loss of research support
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to determine how much the skin on the back can move left to right of the midline and also up and down, in subjects presenting for procedure or in healthy volunteers. The investigators will do measurements on the back using samples of individuals in all age groups.
It is hypothesized that an explanation to late epidural failure could be related to excess back motion in individual subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Age 11-15 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 16-20 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 21-25 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 26-30 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 31-35 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 36-40 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 41-45 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 46-50 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 51-55 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 56-60 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| age 61-65 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 66-70 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 71-75 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 76-80 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 81-85 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 86-90 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 91-95 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 96-100 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 0-5 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
| Age 6-10 | – | Other: measure of skin movement on surface of the back, Other: Measurement of skin movement on surface of back |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals age 0-100
Key inclusion criteria (2 listed)
- Children age 0-17 and Adults 18 and older may participate
- You agree to participate and sign the informed consent document
Key exclusion criteria (4 listed)
- Any type of back deformity
- Tumor on back
- Skin Disease on the back
- Any condition that prevents skin measurements such as scleroderma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure of skin movement on surface of the back | Other | Age 0-5, Age 11-15, Age 16-20, Age 21-25, Age 26-30, Age 31-35, Age 36-40, Age 41-45, Age 46-50, Age 51-55, Age 56-60, Age 6-10, Age 66-70, Age 71-75, Age 76-80, Age 81-85, Age 86-90, Age 91-95, Age 96-100, age 61-65 |
| Measurement of skin movement on surface of back | Other | Age 0-5, Age 11-15, Age 16-20, Age 21-25, Age 26-30, Age 31-35, Age 36-40, Age 41-45, Age 46-50, Age 51-55, Age 56-60, Age 6-10, Age 66-70, Age 71-75, Age 76-80, Age 81-85, Age 86-90, Age 91-95, Age 96-100, age 61-65 |
Primary outcome
Lumbar skin move greater than 4 cm laterally or cephala-caudal
Time frame: Data entered day subject participates
Results and safety
The study was stopped early (reason given: loss of research support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Pantin, MD principal investigator
Rutgers Robert Wood Johnson Medical School
Ann Marie Lozano, RN, MSN study chair
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement of Thoracic and Lumbar Skin, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: loss of research support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar skin move greater than 4 cm laterally or cephala-caudal (time frame: Data entered day subject participates). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.